Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biotone International, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K821691 | STIMRITE | Biotone International, Inc. | 1982-08-25 | 78 | 0 |
| K821692 | PASSIVE HEAT PADS | Biotone International, Inc. | 1982-07-13 | 35 | 0 |
| K812538 | ELITE | Biotone International, Inc. | 1981-12-01 | 89 | 0 |
| K811737 | BIO-TONE MODEL 4 | Biotone International, Inc. | 1981-10-14 | 117 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda